Multiple hemoclip system for an endoscope

ABSTRACT

Spring clips are arranged end to end in a cavity of an inner shaft. Such shaft slides within an outer shaft, and a pusher member slides in the cavity behind the clips. The clips have jaws biased together, but which are wedged apart by an opener as the pusher is moved distally. An opened clip is ejected by relative movement of the inner and outer shafts to clamp body tissue at a desired site.

CROSS-REFERENCES TO RELATED APPLICATIONS

This application is a which is Continuation application of U.S. patentapplication Ser. No. 11/773,936 filed on Jul. 5, 2007, now U.S. Pat. No.8,133,240; which is a Continuation application of U.S. patentapplication Ser. No. 11/351,294 filed on Feb. 9, 2006 (now abandoned);which is a Continuation application of U.S. patent application Ser. No.10/723,433 filed on Nov. 26, 2003 (now U.S. Pat. No. 7,001,399) which isa Continuation application U.S. patent application Ser. No. 10/281,900filed on Oct. 24, 2002 (now U.S. Pat. No. 6,679,894), which claimspriority to U.S. Provisional Patent Application Ser. No. 60/347,832filed on Oct. 24, 2001. All applications/patents are expresslyincorporated herein, in their entirety, by reference.

FIELD OF THE INVENTION

The present invention relates to a system for clipping body tissue, suchas a system for introducing a clip for hemostasis (“hemoclip”)endoscopically in the GI tract.

BACKGROUND OF THE INVENTION

One known system for introducing a hemoclip endoscopically is shown inU.S. Pat. No. 3,958,576 assigned to Olympus Optical Co. Ltd. of Japan.See also Japanese Patent Publication No. 04102450 and U.S. Pat. No.5,766,189. Each of these devices is used to insert a single clip, andincludes a series of mechanical members to insert, eject and close orclamp the clip at a desired location, such as for hemostasis in the GItract.

SUMMARY OF THE INVENTION

The present invention provides an improved hemoclip system. In oneaspect of the invention multiple clips can be applied internally by wayof a conventional endoscope without removal and reinsertion of aclip-retaining member. The system provides good control of the rotatedposition of a clip, with little backlash, for convenient and reliableplacement of a clip or clips.

BRIEF DESCRIPTION OF THE DRAWINGS

The foregoing aspects and many of the attendant advantages of thisinvention will become more readily appreciated as the same become betterunderstood by reference to the following detailed description, whentaken in conjunction with the accompanying drawings, wherein:

FIG. 1 is an enlarged side elevation of the distal portion of a multiplehemoclip system for an endoscope in accordance with the presentinvention with parts shown in section;

FIG. 2 is a distal end elevation of the device of FIG. 1;

FIG. 3 is a transverse section along line 3-3 of FIG. 1, with partsremoved;

FIG. 4 is a top plan of the distal end portion of the device with partsshown in section;

FIG. 5 is a top perspective of a hemoclip usable in the system of thepresent invention;

FIG. 6 is a top perspective of a second embodiment of a hemoclip usablein the system of the present invention;

FIG. 7 is a top perspective of a third embodiment of a hemoclip usablein the system of the present invention;

FIG. 8 is a side elevation of a fourth embodiment of a hemoclip usablein the system of the present invention;

FIG. 9 is a vertical section along line 9-9 of FIG. 5;

FIG. 10 is a vertical section corresponding to FIG. 9 showing aspects ofan alternative embodiment of a hemoclip usable in the system of thepresent invention;

FIG. 11 is a vertical section corresponding to FIG. 9 showing aspects ofa further embodiment of a hemoclip usable in the system of the presentinvention;

FIG. 12 is a diagrammatic top perspective of the proximate portion of amultiple hemoclip system for an endoscope in accordance with the presentinvention;

FIG. 13 is a side elevation of the proximate portion shown in FIG. 12,with parts broken away;

FIG. 14 is a top plan of a second embodiment of a proximate portion of amultiple hemoclip system in accordance with the present invention, withparts broken away;

FIG. 15 is a top plan of a third embodiment of a proximate portion for asystem in accordance with the present invention, with parts broken away;

FIG. 16 is a top plan of a fourth embodiment of proximate portion for asystem in accordance with the present invention, with parts broken away;and

FIG. 17 is a top plan of a fifth embodiment of a proximate portion for asystem in accordance with the present invention, with parts broken away.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

With reference to FIGS. 1-4, a hemoclip system 10 in accordance with thepresent invention includes an elongated outer tube or shaft 12 which maybe inserted through a conventional scope for positioning a distal,clip-carrying portion 14 of the shaft at a desired location of the body,such as a location of bleeding to be clamped. Such elongated outer tubeor shaft 12 can be manufactured from an extruded biocompatible polymeror other suitable material. The proximate end portion of the outer shaftconnects to a handle as described below with reference to FIGS. 12-17for external control of the relatively movable component parts of thedistal portion 14.

An inner shaft 16 is slideably received within the outer shaft 12, andalso may be manufactured from an extruded biocompatible polymer or othersuitable material. The longitudinal position of the inner shaft 16relative to the outer shaft 12 can be adjusted.

The cross-sectional shape of the major portion of the inner shaft 16 isbest seen in FIG. 3. A generally rectangular bore or cavity 18 is sizedfor receiving spring clips 20 of the type described in more detailbelow. To prevent stretching of the inner shaft, support wires 22 can beembedded in it at opposite sides of the central cavity or recess 18.

The cavity 18 is shaped for reception of spring clips 20. Such clips fitclose within the cavity 18 but are freely slideable therein. In general,several clips are preloaded in the distal end of the inner shaft, suchas three or more clips placed end to end. The clips are dispensed, inpart, by a pusher block 24 received in the recess 18 proximate to theclips. The pusher block can be moved distally and proximally bymanipulation of an attached core wire 26. Wire 26 extends through theinner shaft 16 and is slidable therein.

The clips 20 can be manufactured from a metal with spring and/or memoryproperties, such as stainless steel or Nitinol. With reference to FIG.5, the basic shape is a thin band plate, bent toward its center or web28 to form a long U with elongated opposing jaws 30. The ends of thejaws are bent inward to form teeth 32 that face each other. The innerends of the teeth can be sharpened to form grabbing hooks.

Returning to FIGS. 1 and 2, a clip opener component 34 is secured at thedistal end of the inner shaft 16, such as by attachment to thestrengthening wires 22 (shown in the cross-section of FIG. 3). Suchwires preferably extend the full length of the inner shaft. The clipopener includes a continuous shell 36 at its proximate end and two sidepieces 38 at its distal end. As seen in FIG. 4, the proximate portion orshell 36 tapers inward at opposite sides 37 (this tapering and otherdimensions are exaggerated in the drawings for ease of illustration anddescription). The distal or leading ends of the clip jaws are similarlytapered. A clip 20 is “loaded” by forcing it forward, using the pusherblock 24. This has the effect of wedging the side pieces 38 apart untilthe proximate or trailing end of the clip clears the tapered sides 37.After a short travel of the clip distally, the opening between the clipjaws formed by the teeth 32 engage the distal end portions of the sidepieces 38 which project part way into the path that a clip follows whendriven forward by the clip pusher 24. See, for example, the position ofthe side pieces 38 in FIG. 2. The adjacent edges of the side pieces 38are spaced apart transversely but are close enough together so as to beengaged by the tapered leading ends of the clip 20. Each side piece hasproximate wedge surfaces 40 (FIG. 1) angled outward from the center lineof the device and configured such that the distal ends of the clip jawsare wedged apart when the pusher block moves the clip against the openersurfaces 40. Consequently, as a clip is forced forward along the cavity18 of the inner shaft 16, the clip teeth 32 and jaws 30 are wedged apartto the condition illustrated at the right of FIG. 1, contrary to thenatural memory or spring characteristics of the clip. This action tendsto spread the side pieces 38 apart until the central portion or web 28of the clip fits within an intermediate cavity portion 42 of the clipopener 34. When this position is reached, the clip is reliably held inthe clip opener with its jaws open.

The opened clip can be moved by manipulation of the outer shaft or tube12, and can be rotated by manipulation of the inner tube or shaft 16.When a desired site and orientation are reached, such as a bleedingsite, the clip can be ejected by withdrawing the inner shaft 16 relativeto the outer shaft 12. With reference to FIG. 1, projections 44 on theouter sides of the clip jaws 30 are positioned to engage against a metalcollar 46 provided at the end of the outer shaft 12. With reference toFIG. 2, as the inner shaft, including clip opener 34, is retractedwithin the outer tube, the opener side pieces 38 are wedged apart, inthe direction of the arrows 48. In addition, the clip edges can haveweakening nicks 50 (shown only in FIG. 2) that allow the metal of thejaws to bend inward as the jaws move past the opener side pieces 38,until the clip is released and its teeth 32 move toward each other toclamp the tissue at the desired site, due to the inherent spring ormemory characteristics of the clip. After dispensing of one clip, thenext clip can be moved into position by manipulation of the core wire 26and attached pusher 24.

With reference to FIG. 3, the outer periphery of the inner shaft 16 canhave equally spaced ribs 52 for ease in sliding along the innerperiphery of the outer shaft 12. The shafts and core wire 26 can becurved or bent during use, depending on the application.

Different clip geometries may be used, as illustrated in FIGS. 5-11.Preferably the clips are quite wide, at least one millimeter, formaximum spring force. With reference to FIG. 6, one of the teeth 32 canform a sharpened angular projection shaped to be received in acorresponding angular recess of the other tooth 32. The web end 28 ofthe clip can include a circular or helical wire spring member. Withreference to FIG. 7, the web portion 28 of the clip can be narrower thanthe main body portion of the jaws 30, to allow some pivoting movement ofan open clip when in the position at the right of FIG. 2, it beingunderstood that the narrowed portion of the clip web 28 would extendbeyond the distal end of the outer shaft. In that case, the shouldersformed between the web 28 and jaws 30 could be positioned to substitutefor the projections 44. With reference to FIG. 8, closing force for theclip 20 can be achieved or augmented by a separate elastic band 52. Oneor more of the clip components can be bioabsorbable, so that the clipwould automatically be released over time. The clip jaws 30 can be ofrectangular cross-section (FIG. 9) or can be arcuate (FIG. 10) or angled(FIG. 11) for increased rigidity.

With reference to FIGS. 12 and 13, the proximate portion 54 of themultiple hemoclip system in accordance with the present invention can bein the form of a handle having separate components for positioning theouter shaft 12 and manipulating the inner shaft 16 and core wire 26connected to the clip opener and pusher, respectively. The parts areshown diagrammatically. The outer shaft 12 is coupled to a largerfitting 56 leading to a bracket portion 58 that can more easily begrasped and positioned by a user. The inner shaft 16 is coupled to aproximate extension 60 leading to a finger hole 62. Most of theextension 60 is cylindrical, but an operating knob 64 is journaled on ashort noncylindrical portion 66 of the extension. The knob can be turnedto rotate the inner shaft, but is slideable along the noncylindricalportion 66. Sliding movement of the extension relative to the knob 64 islimited by stops 68 at both sides. Since the knob is held within thebracket 58, stops 68 define the maximum travel of the inner shaft 16inside the outer shaft 12.

The core wire 26 is coupled to a sliding spool 70. The spool is moveablefore and aft (distally and proximally) along the extension 60, formoving the core wire and attached clip pusher relative to the innershaft 16. Thus, the proximate portion 54 can be manipulated to positiona clip adjacent to a site to be clamped, whereupon the spool 70 is moveddistally to slide the core wire 26 and clip pusher 24 sufficiently toposition the distal most clip as shown at the right of FIG. 1. Knob 64can be used to rotate the inner shaft to orient the clip as desired.Only a short relative movement of the inner and outer shafts is requiredto eject the clip, which will relax toward its closed position to applya clamping force at the desired site. Thereafter, the device need not beremoved and reloaded. Rather, the next clip can be moved forward and theprocess repeated to secure another clip. Removal of the distal portionof the multiple hemoclip system is not required until the supply ofpreloaded clips has been exhausted.

Other proximate operating mechanisms can be used. In the embodiment ofFIG. 14, the inner shaft 16 is coupled to the long, cylindricalextension 60 leading to the finger hole 62, as in the previouslydescribed embodiment. Also, knob 64 is journaled on, and slideablealong, the non-circular portion 66, with such sliding movement beinglimited by stops 68. However, in the embodiment of FIG. 14, the fitting56 continues to and is affixed to the spool 70. Knob 64 has oppositesides that project through openings in the fitting or housing 56.Relative movement of the extension 60, such as by use of the finger hole62, and the spool 70 results in corresponding relative movement of theinner shaft 16 and outer shaft 12.

In the embodiment of FIG. 14, the core wire 26 connects to a slidemechanism having an external operating button 72 slideably mounted onthe spool structure 70. Indicia 74 adjacent to the button 72 indicatethe position of the pusher block carried by the core wire 26 at itsdistal end. Thus, by viewing the position of the button 72 relative tothe indicia 74, a user will know the position of the clips at the distalend and also the number of clips remaining.

The embodiment of FIG. 15 is identical to the embodiment of FIG. 14except for the mechanism for moving the core wire 26. In thisembodiment, the spool portion 70 carries a rotatable dial 76 havingindicia 78. The core wire 26 connects to or is wrapped around aninternal segment of the dial such that rotation of the dial moves thecore wire 26 (and attached clip pusher) inside the inner shaft 16. Theindicia 78 can be used to determine the position of the clips at thedistal end and/or the number of clips remaining to be dispensed.

In the embodiments of FIGS. 16 and 17, the fitting 56 connected to theouter shaft 12 is identical to that used in the embodiment of FIGS. 12and 13, including the bracket portions 58. In addition, the inner shaft16 connects to the extension 60, with a non-circular segment 66 on whichthe knob 64 is journaled, and stops 68 limiting the relative movement ofthe inner and outer shafts. In the embodiment of FIG. 16, however, thespool section 70 is fixed to the extension 60. Core wire 26 is movedrelative to the spool (and, consequently, relative to the inner shaft)by a slide operating mechanism of the type described above withreference to FIG. 14. The external button 72 is slideable lengthwise ofcomponent 70 for moving the core wire 26, and indicia 74 can be used todetermine the position of the clips and the number of clips remaining.

The embodiment of FIG. 17 is identical to the embodiment of FIG. 16except for the mechanism for moving the core wire 26. In the FIG. 17embodiment, a dial mechanism of the type described above with referenceto FIG. 15 is used. Component 70 is fixed to the inner shaft extension60. Indicia 78 on the dial 76 indicate the position of the clips and thenumber of clips remaining.

While the preferred embodiment of the invention has been illustrated anddescribed, it will be appreciated that various changes can be madetherein without departing from the spirit and scope of the invention.

The embodiments of the invention in which an exclusive property orprivilege is claimed are defined as follows:
 1. A tissue clippingdevice, comprising: an elongated first shaft extending from a proximalend connected to a handle to a distal end and including a first channelextending therethrough; an elongated second shaft extending from aproximal end to a distal end and including a second channel extendingtherethrough, wherein the second shaft is positioned within the firstshaft; a U-shaped clip having first and second jaws movable between anopen configuration in which the first and second jaws are moved radiallyaway from one another to capture a portion of tissue therebetween and aclosed configuration in which the first and second jaws are movedradially toward one another, the clip being biased toward the closedconfiguration; a pusher element enclosed within the second channelproximally of the clip to control distal longitudinal movement of theclip therewithin; a clip opening element adjacent a distal end of thesecond shaft, the clip opening element comprising an elongated shellhaving first and second side arms extending distally therefrom andincluding tapered surfaces contacting distal ends of the first andsecond jaws to move the clip from the closed configuration to the openconfiguration; and a core wire a distal end of which is connected to aproximal portion of the pusher element to control movement thereof, thedistal end of the core wire being housed within the second channel. 2.The device of claim 1, wherein a cross-sectional shape of the secondchannel is substantially rectangular.
 3. The device of claim 1, whereinthe second shaft comprises a first support wire embedded therewithin. 4.The device of claim 3, wherein the second shaft comprises a secondsupport wire embedded therewithin on an opposing side of the firstsupport wire relative to the second channel.
 5. The device of claim 1,wherein the second shaft is longitudinally slidable relative to thefirst shaft to control a movement of the clip.
 6. The device of claim 1,wherein the second shaft is rotatable relative to the first shaft tocontrol a rotational orientation of the clip.
 7. The device of claim 1,wherein an outer surface of the second shaft is ribbed.
 8. The device ofclaim 1, wherein the first and second shafts are formed of abiocompatible polymer.
 9. The device of claim 1, wherein the core wireis connected to an actuation mechanism provided on the handle.
 10. Thedevice of claim 1, wherein distal ends of the first and second jawscomprise teeth sharpened to form hooks.
 11. The device of claim 1,wherein a proximal portion of the shell is tapered.
 12. The device ofclaim 1, further comprising a web joining proximal ends of the first andsecond jaws to one another.
 13. The device of claim 12, wherein the webis one of planar, circular and helical.
 14. The device of claim 1,further comprising a removable elastic band provided over the first andsecond jaws to maintain the clip in the closed configuration.
 15. Atissue clipping system, comprising: an elongated first shaft extendingfrom a proximal end connected to a handle to a distal end and includinga first channel extending therethrough; an elongated second shaftextending from a proximal end to a distal end and including a secondchannel extending therethrough, wherein the second shaft is positionedwithin the first shaft; a plurality of U-shaped clips housed in thesecond channel, each having first and second jaws movable between anopen configuration in which the first and second jaws are moved radiallyaway from one another to capture tissue positioned therebetween and aclosed configuration in which the first and second jaws are movedradially toward one another to grip tissue therebetween, the clips beingbiased toward the closed configuration; a pusher element enclosed withinthe second channel proximal of a proximal-most one of the clips andconfigured to control distal longitudinal movement of the proximal-mostclip therewithin; a clip opening element adjacent a distal end of thesecond shaft, the clip opening element comprising an elongated shellhaving first and second side arms extending distally therefrom andincluding tapered surfaces contacting distal ends of the first andsecond jaws of a distal-most one of the clips to move the distal-mostclip from the closed configured to the open configuration; and a corewire a distal end of which is connected to a proximal portion of thepusher element to control movement thereof, a distal end of the corewire being housed within the second channel.
 16. The system of claim 15,wherein the core wire is connected to an actuation mechanism provided onthe handle.
 17. A method, comprising: inserting a distal portion of atissue clipping device into a living body until distal ends of first andsecond elongated shafts are adjacent target tissue, the first shaftextending between a proximal end connected to a handle and a distal endand including a first channel extending therethrough, the second shaftextending within the first shaft from a second shaft proximal end to asecond shaft distal end and including a second channel extendingtherethrough, wherein the second shaft is positioned within the firstshaft; operating a core wire, a distal end of the core wire is connectedto a proximal portion of a pusher element to push a clip distallythrough the second channel until a distal end thereof contacts a taperedsurfaces of a clip opening element attached to the distal end of thesecond shaft such that contact between the tapered surfaces and thedistal ends of jaws of the clip spread the jaws apart to move the clipto an open configuration, the jaws being biased toward a closedconfiguration, wherein the pusher element is enclosed within the secondchannel proximally of the clip; receiving the target tissue between theopposing jaws of the clip in the open configuration; and releasing thejaws of the clip to capture the target tissue therebetween.
 18. Themethod of claim 17, further comprising rotating the second shaftrelative to the first shaft to rotate the clip to a desired angularorientation.
 19. The method of claim 17, further comprising the step ofmoving the second shaft proximally relative to the first shaft to deploythe clip from the tissue clipping device through a slotted openingdefined between first and second side arms of the clip opening element.20. The method of claim 17, further comprising the step of pivoting theclip in the open configuration to aid in positioning thereof over thetarget tissue.